GCP Compliance Lead

Title: GCP Compliance Lead (Clinical Development – Quality & Compliance)

Responsibilities:
- Establish, maintain, and continuously improve the organization’s Good Clinical Practice (GCP) compliance framework to ensure subject safety, data integrity, and ethical principles across the clinical lifecycle
- Advise internal/external stakeholders on GCP matters
- Lead a team assessing compliance with global regulations/guidelines, corporate policies, and SOPs
- Partner with GVP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program
- Support planning and execution of GCP regulatory inspections; identify and help resolve regulatory compliance risks and related issues
- Champion Global Quality vision, policies, processes, and decisions
- Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
- Support and drive quality and compliance projects and objectives
- Stay current on regulations and recommend proactive compliance changes
- Develop and enhance GCP compliance processes and best practices; maintain processes for evaluation/escalation of serious non-compliance
- Lead execution of the GCP Compliance Global Audit Program
- Serve on regulatory inspection teams and support mock readiness activities
- Provide insights to optimize the GCP Compliance Audit Program
- Build and lead a high-functioning team; foster a culture of teamwork and mutual respect
- Mentor/develop staff; conduct management activities (staffing, budget monitoring, strategic planning)
- Manage recruiting, hiring, and evaluations with HR and Global Quality leadership

Required Skills/Qualifications:
- 10+ years in a regulated healthcare industry in quality and compliance
- Working knowledge of FDA, EMA, PMDA, global PV regulations; application of GCP and ICH/GCP regulations
- Experience in Clinical Development within Quality and Compliance
- Experience executing/managing Health Authority Inspections
- Experience executing/managing R&D Audits and a GCP Audit Program
- Experience designing GCP audit strategy with internal auditors and external consultants
- Experience working with/understanding a quality management system
- Leadership competencies: strategic thinking, agility, prioritization, communication, decision-making
- Experience managing staff and leading teams
- Strong communication skills; able to present to senior leadership
- Ability to work independently and adapt to rapidly changing priorities
- Strong computer skills (MS Suite) and interfacing with Quality Management Systems

Desired Skills:
- Experience with business development partnerships, mergers, and/or acquisitions
- Oversight/management of Computer System Validation (CSV) / Data Integrity (CSDI) audits
- Exposure to any phase of pharmaceutical drug development
- Awareness of clinical responsibilities (e.g., study start-up, protocol design, quality risk management, trial conduct, monitoring, data management, Trial Master File/eTMF)

Education:
- Bachelor’s degree in a life science focus area; master’s degree preferred

Work Arrangement / Travel:
- Remote (US time zones) flexibility; hybrid expectations for staff local to SRC and Novato offices
- Travel up to 10–20%